Frontage Laboratories, Inc
Associate Director QA - Pharmaceutical Manufacturing
Frontage Laboratories, Inc - Exton, Pennsylvania, United States
Work at Frontage Laboratories, Inc
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Overview
Associate Director QA - Pharmaceutical Manufacturing
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Associate Director QA - Pharmaceutical Manufacturing
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Frontage Laboratories, Inc Associate Director QA - Pharmaceutical Manufacturing
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Associate Director QA - Pharmaceutical Manufacturing
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Frontage Laboratories, Inc Direct message the job poster from Frontage Laboratories, Inc Associate Director of Quality Assurance, Pharmaceutical Manufacturing
Title:
Associate Director of Quality Assurance, Pharmaceutical Manufacturing
Location:
Exton, PA
Reports to : Director of Quality Assurance, CMC
Position type : Full-time.
Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary
The Associate Director of Quality Assurance, Pharmaceutical Manufacturingplays a critical role in the development, maintenance, and continuous improvement of quality management systems for late phase clinical and small scale commercial pharmaceutical manufacturing operation to uphold quality standards and GMP compliance and ensure seamless integration with global quality processes.
The Associate Director of Quality Assurance, Pharmaceutical Manufacturingmonitors manufacturing, packaging, releasing, disposition, testing and validation activities, performs product inspections, and verifies process and product documentation. The Associate Director, QA also identifies risks and deficiencies, conducts root cause analysis, and checks CAPA effectiveness.
Responsibilities
Manage the quality assurance team to support the GMP manufacturing of drug dosage forms for preclinical and clinical trial studies, and commercial production. The dosage forms include oral solid and liquid, semisolid, and sterile etc. Manage internal audits and provide biannual quality KPI analysis to CMC/CDMO management. Host regulatory agent inspection such as FDA, EU QP, and DEA. Provide responses to ensure quality compliance. Oversee controlled substance program with strict adherence Host client audits and provide timely responses to audit reports as well as manage related CAPAs. Develop and approve quality agreements with clients, host client audit and provide responses, and ensure action items are completed to meet the requirements. Develop, implement, and oversee quality systems at Frontage manufacturing facility to ensure product reliability, quality, efficacy, and alignment with global standards. Develop, maintain, and continuously Review and approve quality documents such as SOP, change controls, OOS, Deviations, CAPAs, MV protocols, MV reports, batch records, COA, product release with the statement of GMP compliance. Manage supplier qualification including quality agreement and audit report. Improve and train employees in quality culture. Provide staff with annual GMP training with expertise and guidance in interpreting and implementing government and agency guidelines to ensure current GMP compliance. Maintain and continuously improve the use of electronic quality management system, ZenQMS. Other duties as assigned.
Education, Experience & Skills Required
BS or advanced degree in a scientific discipline or related area 10-15 years of experience in pharmaceutical/biotech industry, including manufacturing, development, and quality 6-8 years of experience in quality management and leadership positions 5 years of experience in the quality for late phase clinical trial material and commercial drug manufacturing of various format such as solid, semisolid, sterile liquids etc. Demonstrate strong knowledge of US, EMA and ICH regulations, guidance, and industry standards for CGMP (21 CFR Part 210, 211) Experience in hosting regulatory authorities’ inspections and providing responses. Experience with controlled substances and familiarity with DEA regulations. Thorough understanding of GMP regulations and industry practices in terms of key quality performance indicators (KPI) Strong working knowledge of pharmaceutical quality systems (deviations, CAPA, GMP change controls) Experience leading deviation and non-conforming material investigations. Demonstrated success in coaching, mentoring, and training across functions. Excellent written, oral, and interpersonal communication skills. Ability to think and act strategically. Self-directed, multi-tasker and ability to work effectively with cross-functional teams. Proven technical writing/editing skills and problem-solving ability. Strong attention to detail, excellent organization skills and cultural fit. Proficiency in Microsoft Office applications Ability to operate in a fast-paced, multi-disciplinary virtual environment. CDMO or CRO experience preferred.
Salary And Benefits
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Research Services Referrals increase your chances of interviewing at Frontage Laboratories, Inc by 2x Get notified about new Associate Director Quality Assurance jobs in
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Join to apply for the
Associate Director QA - Pharmaceutical Manufacturing
role at
Frontage Laboratories, Inc Associate Director QA - Pharmaceutical Manufacturing
Join to apply for the
Associate Director QA - Pharmaceutical Manufacturing
role at
Frontage Laboratories, Inc Direct message the job poster from Frontage Laboratories, Inc Associate Director of Quality Assurance, Pharmaceutical Manufacturing
Title:
Associate Director of Quality Assurance, Pharmaceutical Manufacturing
Location:
Exton, PA
Reports to : Director of Quality Assurance, CMC
Position type : Full-time.
Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary
The Associate Director of Quality Assurance, Pharmaceutical Manufacturingplays a critical role in the development, maintenance, and continuous improvement of quality management systems for late phase clinical and small scale commercial pharmaceutical manufacturing operation to uphold quality standards and GMP compliance and ensure seamless integration with global quality processes.
The Associate Director of Quality Assurance, Pharmaceutical Manufacturingmonitors manufacturing, packaging, releasing, disposition, testing and validation activities, performs product inspections, and verifies process and product documentation. The Associate Director, QA also identifies risks and deficiencies, conducts root cause analysis, and checks CAPA effectiveness.
Responsibilities
Manage the quality assurance team to support the GMP manufacturing of drug dosage forms for preclinical and clinical trial studies, and commercial production. The dosage forms include oral solid and liquid, semisolid, and sterile etc. Manage internal audits and provide biannual quality KPI analysis to CMC/CDMO management. Host regulatory agent inspection such as FDA, EU QP, and DEA. Provide responses to ensure quality compliance. Oversee controlled substance program with strict adherence Host client audits and provide timely responses to audit reports as well as manage related CAPAs. Develop and approve quality agreements with clients, host client audit and provide responses, and ensure action items are completed to meet the requirements. Develop, implement, and oversee quality systems at Frontage manufacturing facility to ensure product reliability, quality, efficacy, and alignment with global standards. Develop, maintain, and continuously Review and approve quality documents such as SOP, change controls, OOS, Deviations, CAPAs, MV protocols, MV reports, batch records, COA, product release with the statement of GMP compliance. Manage supplier qualification including quality agreement and audit report. Improve and train employees in quality culture. Provide staff with annual GMP training with expertise and guidance in interpreting and implementing government and agency guidelines to ensure current GMP compliance. Maintain and continuously improve the use of electronic quality management system, ZenQMS. Other duties as assigned.
Education, Experience & Skills Required
BS or advanced degree in a scientific discipline or related area 10-15 years of experience in pharmaceutical/biotech industry, including manufacturing, development, and quality 6-8 years of experience in quality management and leadership positions 5 years of experience in the quality for late phase clinical trial material and commercial drug manufacturing of various format such as solid, semisolid, sterile liquids etc. Demonstrate strong knowledge of US, EMA and ICH regulations, guidance, and industry standards for CGMP (21 CFR Part 210, 211) Experience in hosting regulatory authorities’ inspections and providing responses. Experience with controlled substances and familiarity with DEA regulations. Thorough understanding of GMP regulations and industry practices in terms of key quality performance indicators (KPI) Strong working knowledge of pharmaceutical quality systems (deviations, CAPA, GMP change controls) Experience leading deviation and non-conforming material investigations. Demonstrated success in coaching, mentoring, and training across functions. Excellent written, oral, and interpersonal communication skills. Ability to think and act strategically. Self-directed, multi-tasker and ability to work effectively with cross-functional teams. Proven technical writing/editing skills and problem-solving ability. Strong attention to detail, excellent organization skills and cultural fit. Proficiency in Microsoft Office applications Ability to operate in a fast-paced, multi-disciplinary virtual environment. CDMO or CRO experience preferred.
Salary And Benefits
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Research Services Referrals increase your chances of interviewing at Frontage Laboratories, Inc by 2x Get notified about new Associate Director Quality Assurance jobs in
Exton, PA . Audit Methodology & Quality Assurance Manager
Manager, Business Analysis & Quality Assurance
Audubon, PA $87,500.00-$125,000.00 5 days ago Associate Director, Regulatory Affairs - Labeling Management
North Wales, PA $126,500.00-$199,100.00 1 hour ago Associate Director, Regulatory Affairs - Labeling Management
Associate Director, Biologics Operations Upstream & Downstream, Biopharmaceutical Development
Associate Regulatory Affairs CMC Director (Small Molecule)
King of Prussia, PA $166,000.00-$236,500.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr